Ischemic StrokePhase 3NCT00361699
hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)
A Phase 3 study testing Statin in people with Ischemic Stroke, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 2 sites in Japan.
Trial summary
Inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can play a role in preventing recurrent vascular events from ischemic heart disease patients, whose mechanism consists in not only the reduction of serum lipid level but also anti-inflammatory effects. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Statin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,095 participants
- Where
- 2 sitesJapan
- Study dates
- Mar 2004to Jul 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
- Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days
- Able to visit outpatient department
- Informed consent on the form filled in by the patient.
Who cannot join
- Ischemic stroke of other determined cause according to the TOAST classification
- Ischemic heart disease and necessary to use statin
- Hemorrhagic disorders
- Platelet count <=100,000/ul within 3 months prior to study start
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>= 100IU/L within 3 months prior to study start
- Serum creatinine >=2.0mg/dl within 3 months prior to study start
- A scheduled operation
- The presence of malignant disorder
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Hiroshima University Hospital
Hiroashima, Hiroshima, 734-8551
Osaka University
Suita-shi, Osaka, 565-0871
About this study
Official title: Effect of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) Reductase Inhibitor Upon the Serum High Sensitive CRP in the Post-ischemic Patients With Hyperlipidemia During the Prospective Study of J-STARS.
Inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can play a role in preventing recurrent vascular events from ischemic heart disease patients, whose mechanism consists in not only the reduction of serum lipid level but also anti-inflammatory effects. Serum high sensitive CRP is known to be a predictor of cardiovascular events independent of other conventional risk factors. The present substudy examine whether such pleiotrophic effect of HMG-CoA reductase inhibitor (statin) which decreases high sensitive CRP would be observed in the post-ischemic stroke patients who have already been registered in the J-STARS, and the relationship the values of high sensitive CRP and recurrence of stroke.
- Conditions
- Ischemic Stroke
- Being tested
- Statin
- Keywords
- stroke, brain ischemia, cerebrovascular accident, statin, hydroxymethylglutaryl-CoA reductase inhibitors, cholesterol, hypercholesterolemia, hyperlipidemia, multicenter studies, prospective studies, endpoint determination, randomized controlled trials, recurrence, pravastatin, c-reactive Protein
- Medical subject headings
- Ischemic Stroke, Stroke, Brain Ischemia, Hypercholesterolemia, Hyperlipidemias, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Pravastatin | Active comparator | Patient has 10mg oral administration of Pravastatin per day. It starts within one month from their entry and continues every day until the end of the study or its endpoints. Receives: Drug: Statin |
| No intervention | No intervention | Patient has no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum level of high sensitive CRP
Measured: until the last day of the next February after 5-year follow-up survey
Secondary outcomes (1)
recurrent stroke
Measured: until the last day of the next February after 5-year follow-up survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startMar 2004
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,095 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan, Hiroshima University, Osaka University
- Responsible party
- Sponsor
- Investigators
- Masayasu Matsumoto, MD, PhD, Principal investigator, Hiroshima University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361699
- Sponsor's protocol ID
- J-STARS hsCRP
- Other IDs
- C000000211
- Status last verified
- Apr 2016
- First submitted
- 7 Aug 2006
- Last updated
- 25 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) Reductase Inhibitor Upon the Serum High Sensitive CRP in the Post-ischemic Patients With Hyperlipidemia During the Prospective Study of J-STARS.
- ClinicalTrials.gov ID
- NCT00361699
- Acronym / sponsor ID
- J-STARS hsCRP
- Conditions
- Ischemic Stroke
- Keywords
- stroke, brain ischemia, cerebrovascular accident, statin, hydroxymethylglutaryl-CoA reductase inhibitors, cholesterol, hypercholesterolemia, hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,095 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan, Hiroshima University, Osaka University
- Study start
- Mar 2004
- Primary completion
- Jul 2014 (actual)
- First posted
- 8 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can play a role in preventing recurrent vascular events from ischemic heart disease patients, whose mechanism consists in not only the reduction of serum lipid level but also anti-inflammatory effects. Serum high sensitive CRP is known to be a predictor of cardiovascular events independent of other conventional risk factors. The present substudy examine whether such pleiotrophic effect of HMG-CoA reductase inhibitor (statin) which decreases high sensitive CRP would be observed in the post-ischemic stroke patients who have already been registered in the J-STARS, and the relationship the values of high sensitive CRP and recurrence of stroke.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pravastatin | Active comparator | Drug: StatinPatient has 10mg oral administration of Pravastatin per day. It starts within one month from their entry and continues every day until the end of the study or its endpoints. |
| No intervention | No intervention | –Patient has no intervention. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
- Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days
- Able to visit outpatient department
- Informed consent on the form filled in by the patient.
Key exclusion criteria (8 listed)
- Ischemic stroke of other determined cause according to the TOAST classification
- Ischemic heart disease and necessary to use statin
- Hemorrhagic disorders
- Platelet count <=100,000/ul within 3 months prior to study start
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>= 100IU/L within 3 months prior to study start
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statin | Drug | Pravastatin |
Primary outcome
serum level of high sensitive CRP
Time frame: until the last day of the next February after 5-year follow-up survey
1 secondary outcome
recurrent stroke
Time frame: until the last day of the next February after 5-year follow-up survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Available only in JapaneseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masayasu Matsumoto, MD, PhD principal investigator
Hiroshima University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Statin in people with Ischemic Stroke, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum level of high sensitive CRP (time frame: until the last day of the next February after 5-year follow-up survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2016.